|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Extent of Recognition
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Standard Title (click for recognition information)
|
12/20/2021 |
Ophthalmic |
10-130 |
Complete |
ANSI |
Z80.36-2021 |
American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments |
12/20/2021 |
Dental/ ENT |
4-284 |
Complete |
ISO |
10873 Second edition 2021-07 |
Dentistry - Denture adhesives |
12/19/2022 |
Dental/ ENT |
4-296 |
Complete |
ISO |
9873 Fourth edition 2019-03 |
Dentistry - Intra-oral mirrors |
ANSI ADA |
Standard No. 191-2020 |
Intra-Oral Mirrors |
12/19/2022 |
Dental/ ENT |
4-297 |
Complete |
ISO |
20126 Third edition 2022-03 |
Dentistry - Manual toothbrushes - General requirements and test methods |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-119 |
Complete |
IEC |
60601-2-36 Edition 2.0 2014-04 |
Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy |
09/17/2018 |
Cardiovascular |
3-154 |
Complete |
ASTM |
F3211-17 |
Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices |
04/04/2016 |
Materials |
8-413 |
Complete |
ASTM |
F2819-10 (Reapproved 2015) |
Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices |
02/07/2022 |
General II (ES/ EMC) |
19-45 |
Complete |
AIM |
Standard 7351731 Rev. 3.00 2021-06-04 |
Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard |
12/20/2021 |
Orthopedic |
11-392 |
Complete |
ASTM |
F2723-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation |
12/19/2022 |
General I (QS/ RM) |
5-139 |
Complete |
ISO |
18250-3 First edition 2018-06 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application |
07/09/2014 |
Materials |
8-379 |
Complete |
ISO |
11542-2 First edition 1998-11-15 |
Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)] |
01/30/2014 |
Neurology |
17-12 |
Complete |
ISO |
7197 Third edition 2006-06-01 |
Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)] |
12/23/2016 |
Orthopedic |
11-312 |
Complete |
ISO |
7206-4 Third edition 2010-06-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)] |
06/07/2021 |
Orthopedic |
11-384 |
Complete |
ASTM |
F3446-20 |
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator |
12/19/2022 |
Dental/ ENT |
4-294 |
Complete |
ANSI ADA |
Standard No. 139-2020 |
Dental Base Polymers |
12/19/2022 |
Ophthalmic |
10-133 |
Complete |
ISO |
11979-10 Second edition 2018-03 |
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes. |
12/19/2022 |
Software/ Informatics |
13-122 |
Complete |
IEC |
81001-5-1 Edition 1.0 2021-12 |
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
|
01/27/2015 |
Orthopedic |
11-283 |
Complete |
ASTM |
F2943-14 (Reapproved 2019) |
Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty |
07/06/2020 |
Nanotechnology |
18-16 |
Complete |
ISO |
TS 21362 First edition 2018-06 |
Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation |
12/20/2021 |
Cardiovascular |
3-176 |
Complete |
ISO |
18193 First edition 2021-08 |
Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation |
12/20/2021 |
Cardiovascular |
3-177 |
Complete |
ASTM |
F2606-08 (Reapproved 2021) |
Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems |
12/20/2021 |
Nanotechnology |
18-19 |
Complete |
ISO |
19749 First edition 2021-07 |
Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy |
12/20/2021 |
Nanotechnology |
18-20 |
Complete |
ASTM |
E3275-21 |
Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis |
12/20/2021 |
Dental/ ENT |
4-285 |
Complete |
ANSI ADA |
Standard No. 37-1986 (R2020) |
Dental Abrasive Powders |
01/14/2019 |
Orthopedic |
11-342 |
Complete |
ASTM |
F732-17 |
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
01/14/2019 |
Orthopedic |
11-343 |
Complete |
ASTM |
F2346-18 |
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs |
01/14/2019 |
Materials |
8-489 |
Complete |
ASTM |
F3302-18 |
Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Titanium Alloys via Powder Bed Fusion |
01/14/2019 |
Orthopedic |
11-272 |
Complete |
ASTM |
F1714-96 (Reapproved 2018) |
Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
12/19/2022 |
Software/ Informatics |
13-123 |
Complete |
ANSI NEMA |
HN 1-2019 |
American National Standard Manufacturer Disclosure Statement for Medical Device Security |
12/19/2022 |
Software/ Informatics |
13-124 |
Complete |
AAMI |
CR34971:2022 |
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning |
12/19/2022 |
Software/ Informatics |
13-125 |
Complete |
ANSI AAMI UL |
2800-1-1:2022 |
Standard for Risk Concerns for Interoperable Medical Products |
12/20/2021 |
Sterility |
14-563 |
Complete |
ISO |
13408-6 Second edition 2021-04 |
Aseptic processing of health care products - Part 6: Isolator systems |
01/27/2015 |
Dental/ ENT |
4-136 |
Complete |
ASTM |
F2504-05 (Reapproved 2022) |
Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices |
07/09/2014 |
Dental/ ENT |
4-149 |
Complete |
ANSI ADA |
Standard No. 39-2006 (R2011) |
Pit and Fissure Sealants |
07/09/2014 |
Dental/ ENT |
4-160 |
Complete |
ANSI ASA |
S3.1-1999 (Reaffirmed 2023) |
American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms |
08/06/2013 |
Dental/ ENT |
4-204 |
Complete |
ANSI ASA |
S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) |
American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard) |
12/19/2022 |
Orthopedic |
11-396 |
Complete |
ISO |
7206-13 First edition 2016-07-01 [Including AMD1:2022] |
Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)] |
12/20/2021 |
Materials |
8-563 |
Complete |
ASTM |
F1801-20 |
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
12/23/2019 |
Anesthesiology |
1-145 |
Complete |
ISO |
19223 First edition 2019-07 |
Lung ventilators and related equipment - Vocabulary and semantics. |
12/23/2019 |
General Plastic Surgery/ General Hospital |
6-437 |
Complete |
ISO |
23907-2 First edition 2019-11 |
Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers. |
05/30/2022 |
Materials |
8-590 |
Complete |
ISO |
TS 17137 Third edition 2021-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
08/21/2017 |
Dental/ ENT |
4-239 |
Complete |
ANSI AAMI |
CI86:2017 |
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
01/14/2019 |
Biocompatibility |
2-141 |
Complete |
ASTM |
F1984-99 (Reapproved 2018) |
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
04/04/2016 |
General II (ES/ EMC) |
19-17 |
Complete |
IEEE ANSI |
C63.18-2014 |
American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters |
04/04/2016 |
Tissue Engineering |
15-24 |
Complete |
ASTM |
F2721-09 (Reapproved 2014) |
Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects |
12/19/2022 |
Nanotechnology |
18-21 |
Complete |
ISO |
TS 80004-6 Second edition 2021-03 |
Nanotechnologies - Vocabulary - Part 6: Nano-object characterization |
12/20/2021 |
Orthopedic |
11-390 |
Complete |
ISO |
23089-2 First edition 2021-05 |
Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices |
07/15/2019 |
Orthopedic |
11-356 |
Complete |
ISO |
15142-2 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components |
06/07/2021 |
Materials |
8-560 |
Complete |
ASTM |
D1415-18 |
Standard Test Method for Rubber Property - International Hardness |
06/07/2021 |
General Plastic Surgery/ General Hospital |
6-462 |
Complete |
IEC |
60601-2-20 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
12/21/2020 |
General I (QS/ RM) |
5-133 |
Complete |
ISO |
80369-7 Second edition 2021-05 |
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications |
04/04/2016 |
Ophthalmic |
10-100 |
Complete |
ISO |
18259 First Edition 2014-10-01 |
Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms |
08/21/2017 |
Dental/ ENT |
4-232 |
Complete |
ISO |
20795-1 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 1: Denture base polymers |
08/06/2013 |
Software/ Informatics |
13-42 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-2:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
IEC |
TR 80001-2-2 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
01/14/2019 |
Tissue Engineering |
15-47 |
Complete |
ISO |
22442-3 First edition 2007-12-15 |
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents. |
12/23/2024 |
Dental/ ENT |
4-336 |
Complete |
ISO |
18397 First edition 2016-01 |
Dentistry - Powered scaler |
ANSI ADA |
Standard No. 157-2020 |
Powered Dental Scaler Handpieces and Tips |
05/29/2024 |
Anesthesiology |
1-169 |
Complete |
CGA |
V-1:2021 |
Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection |
06/07/2021 |
Tissue Engineering |
15-67 |
Complete |
ASTM |
F2212-20 |
Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
01/30/2014 |
Cardiovascular |
3-118 |
Complete |
ANSI AAMI |
EC57:2012 |
Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms |
06/07/2018 |
ObGyn/ Gastroenterology/ Urology |
9-114 |
Complete |
IEC |
60601-2-18: Edition 3.0 2009-08 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
08/21/2017 |
Materials |
8-449 |
Complete |
ASTM |
F1058-16 |
Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008) |
01/30/2014 |
Radiology |
12-59 |
Complete |
IEC |
61168:1993 |
Radiotherapy simulators - Functional performance characteristics |
01/30/2014 |
Radiology |
12-264 |
Complete |
NEMA |
MS 11-2010 |
Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging |
06/07/2018 |
Radiology |
12-312 |
Complete |
IEC |
61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION |
Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response |
06/07/2018 |
Radiology |
12-313 |
Complete |
IEC |
TS 62462 Edition 2.0 2017-07 |
Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems |
01/30/2014 |
InVitro Diagnostics |
7-239 |
Complete |
CLSI |
EP32-R (Formerly X05-R) |
Metrological Traceability and Its Implementation; A Report |
08/14/2015 |
Dental/ ENT |
4-130 |
Complete |
ANSI ADA |
Standard No. 17-1983 (R2014) |
Denture Base Temporary Relining Resins |
07/09/2014 |
Software/ Informatics |
13-65 |
Complete |
UL ANSI |
1998 Third Edition 2013 |
Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008] |
01/14/2019 |
Biocompatibility |
2-145 |
Complete |
ASTM |
F1439-03 (Reapproved 2018) |
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
07/06/2020 |
Materials |
8-527 |
Complete |
ASTM |
F899-20 |
Standard Specification for Wrought Stainless Steels for Surgical Instruments |
06/07/2021 |
General II (ES/ EMC) |
19-40 |
Complete |
IEC |
60086-4 Edition 5.0 2019-04 |
Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)] |
12/23/2019 |
Physical Medicine |
16-219 |
Complete |
RESNA ANSI |
WC-2:2019 Section 14 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods |
12/21/2020 |
Biocompatibility |
2-283 |
Complete |
ASTM |
F619-20 |
Standard Practice for Extraction of Materials Used in Medical Devices |
12/21/2020 |
Dental/ ENT |
4-271 |
Complete |
ANSI ADA |
Standard No. 34-2013 |
Dental Cartridge Syringes |
07/09/2014 |
Dental/ ENT |
4-165 |
Complete |
ANSI ASA |
S3.13-1987 (Reaffirmed 2024) |
American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-88 |
Complete |
ISO |
29942 First edition 2011-07-01 |
Prophylatic dams -- Requirements and test methods |
04/04/2016 |
Radiology |
12-196 |
Complete |
NEMA |
MS 2-2008 (R2020) |
Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images |
08/06/2013 |
Physical Medicine |
16-190 |
Complete |
ISO |
7176-11 Second edition 2012-12-01 |
Wheelchairs - Part 11: Test dummies |
08/06/2013 |
Physical Medicine |
16-192 |
Complete |
ISO |
7176-3 Third edition 2012-12-15 |
Wheelchairs - Part 3: Determination of effectiveness of brakes |
04/04/2016 |
Radiology |
12-288 |
Complete |
NEMA |
MS 9-2008 (R2020) |
Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images |
07/09/2014 |
InVitro Diagnostics |
7-175 |
Complete |
CLSI |
C59-A |
Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-85 |
Complete |
ASTM |
D6976-13R18 |
Standard Specification for Rubber Contraceptives - Vaginal Diaphragms |
01/14/2019 |
InVitro Diagnostics |
7-232 |
Complete |
CLSI |
MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 |
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition |
12/19/2022 |
Sterility |
14-580 |
Complete |
ISO |
11137-2 Third edition 2013-06 [Including AMD1:2022] |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)] |
12/20/2021 |
Radiology |
12-341 |
Complete |
IEC |
62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION |
Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods |
01/14/2019 |
Orthopedic |
11-346 |
Complete |
ASTM |
F2706-18 |
Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model |
12/04/2017 |
Software/ Informatics |
13-102 |
Complete |
IEC |
TR 80001-2-8 Edition 1.0 2016-05 |
Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 |
07/06/2020 |
Materials |
8-536 |
Complete |
ISO ASTM |
52902:First Edition 2019-07 |
Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems |
07/15/2019 |
Sterility |
14-533 |
Complete |
ISO |
TS 19930 First edition 2017-12 |
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
06/07/2021 |
Materials |
8-556 |
Complete |
ASTM |
F640-20 |
Standard Test Methods for Determining Radiopacity for Medical Use |
12/23/2016 |
Software/ Informatics |
13-87 |
Complete |
ISO IEC |
15026-2 First edition 2011-02-15 |
Systems and software engineering - Systems and software assurance - Part 2: Assurance case |
01/14/2019 |
Orthopedic |
11-347 |
Complete |
ASTM |
F2077-18 |
Test Methods for Intervertebral Body Fusion Devices |
12/23/2019 |
Physical Medicine |
16-216 |
Complete |
RESNA ANSI |
WC-2:2019 Section 10 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
12/23/2019 |
Physical Medicine |
16-217 |
Complete |
RESNA ANSI |
WC-1:2019 Section 11 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins |
12/23/2019 |
Physical Medicine |
16-220 |
Complete |
RESNA ANSI |
WC-1:2019 Section 15 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling |
12/23/2019 |
Physical Medicine |
16-221 |
Complete |
RESNA ANSI |
WC-1:2019 Section 16 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods |
08/14/2015 |
Sterility |
14-463 |
Complete |
ISO ASTM |
51608 Second edition 2015-03-15 |
Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV |
04/04/2016 |
General Plastic Surgery/ General Hospital |
6-355 |
Complete |
ASTM |
D3772-15(2021) |
Standard Specification for Industrial Rubber Finger Cots |
01/27/2015 |
Radiology |
12-230 |
Complete |
NEMA |
XR 24-2008 (R2014) |
Primary user controls for interventional angiography x-ray equipment |
01/27/2015 |
Radiology |
12-286 |
Complete |
NEMA |
XR 27 Amendment 1-2013 |
X-ray equipment for interventional procedures - User Quality Control Mode |